There’s an important meeting happening at NIH today and tomorrow, but you probably know nothing about it. The secrecy of this meeting is intentional, and the implications of decisions made at the meeting are as far-reaching as the Institute of Medicine study. In fact, what I’ve learned about the meeting may strike you as worse than the IOM study process.
TL;DR Version
- The P2P Working Group roster has not been made public.
- The P2P Working Group will finalize the study questions for the evidence review and workshop.
- I can exclusively reveal who was contracted to conduct that evidence review.
- I can exclusively reveal the draft study questions.
- The P2P panel, which will conduct the Workshop and write its report, will be 100% non-ME/CFS experts.
What Meeting Is This?
January 6-7th is the first meeting of the Working Group for the Pathways to Prevention Workshop on ME/CFS. You may be more familiar with the old name for the meeting, the NIH Evidence-based Methodology Workshop. At the May 2013 CFS Advisory Committee meeting, Dr. Susan Maier clarified the purpose of the Workshop “is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue.” The Workshop itself will not create a research definition for ME/CFS, but Dr. Nancy Lee said that the output of the workshop could be used to inform such a definition. (CFSAC Minutes, May 23, 2013, pp. 6, 48-49)
The Pathways to Prevention Program (P2P) is operated through NIH’s Office of Disease Prevention. Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC).
At today’s meeting, the Working Group will finalize the study questions that frame the entire workshop process. Obviously, the questions are of critical importance since they form the basis for the evidence review and technical brief, as well as the public workshop itself. But before we get to the questions, don’t you want to know who is on the Working Group?
Who Is On This Working Group?
Guess what? We don’t know. At the May 2013 CFSAC meeting, Dr. Maier reported that 35-40 potential names were forwarded to the Office of Disease Prevention for possible service on the Working Group. She said that the list included ME/CFS experts, advocates and patients, including some CFSAC members. Despite vigorous objections expressed by Dr. Mary Ann Fletcher, Dr. Maier did not share the list, did not allow CFSAC to provide input, nor did she indicate a timeline for the release of that roster. (CFSAC Minutes, May 23, 2013, pp. 8, 49)
Unfortunately, Dr. Maier also did not provide the roster at the December 2013 CFSAC meeting and, to my dismay, no one on CFSAC asked her about it. Dr. Maier has also refused an individual request for the roster prior to the meeting, citing “standard procedure,” and there is no indication whether or when that information will be made public.
Why is this a big deal? Because the Working Group helps shape the entire workshop process. According to the P2P site, “the Working Group is involved from the beginning to the end of the workshop planning process; it finalizes the questions that frame the workshop, nominates panelists and speakers, and selects the date of the workshop.” Interestingly, the Working Group is made up of “content area experts from the federal government, academia, and clinical practice.” Dr. Maier said the nomination list included advocates and patients, but we have no way of knowing if any were actually appointed to the Working Group.
The Study Questions
Dr. Beth Collins Sharp described the evidence review process in detail at the May 2013 CFSAC meeting. One of the AHRQ EPCs is contracted to conduct a comprehensive evidence review based on study questions. Those study questions were drafted by unknown federal employees, and are finalized with the input of the Working Group, the EPC and federal participants. This is happening today and tomorrow.
As Dr. Collins-Sharp said in May, “You can’t get the right answer if you don’t ask the right questions.” (CFSAC Minutes, May 23, 2013, p. 12) However, Drs. Maier and Collins-Sharp have refused an individual request for the study questions being presented to the Working Group today, and have said only that the final questions will be posted by AHRQ and ODP but provided no timeline for this. Incidentally, they have also refused to disclose which EPC was contracted to perform this review.
However, I can answer both those questions today because I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211. I will discuss this contract in more detail in a future post. For now, I draw your attention to the draft questions as stated in the Task Order, and presumably being presented to the Working Group today:
I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?
II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?
III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?
IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?
V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?
There are so many issues with this list. For starters:
- Asking whether ME and CFS differ is critical (I), but this question fails to ask whether the mixed bag of “CFS” is even a valid clinical entity to begin with. It’s also important to note that the remainder of the questions (II-V) revert to lumping ME and CFS back together as one illness.
- Question II asks what tools/measurements can be used to identify subsets along the whole spectrum, i.e. NOT whether such a “subset” actually represents a separate illness. It also asks if there is a subset not defined by current tools and measurements. Huh? How could a subset be identified if there are no tools/measurements to identify them?
- Question III, the characteristics of patients who do or do not respond to treatment, rests in part on case definition. Will a systematic review dig into the raw data on studies such as the PACE trial or Ampligen trials to identify characteristics of responders and non-responders? Can applicable case definitions in those study cohorts even be assessed retrospectively (e.g. to examine a Fukuda cohort to see how many met the Canadian criteria)? Will the systematic review treat studies with different case definitions as equivalent (e.g. Oxford studies are as valid and relevant as Fukuda studies)?
- Question IV strikes me as the question actually being posed in the IOM study. The IOM will be identifying the evidence for various diagnostic criteria, and then develop evidence-based clinical diagnostic criteria. Including the same type of question here seems needlessly duplicative. And what if the two evidence reviews come up with different answers?
- Finally, I can answer Question V myself: it’s both. There are a number of key clinician-researchers who maintain a clinical ME/CFS practice and conduct research. For those individuals, their research influences their clinical care and vice versa. But for the rest of the world, we know that clinical care is completely divorced from ME/CFS research. Based on the horror stories we hear from patients, based on the dramatic under-diagnosis of the disease and simultaneous use of CFS as a wastebasket diagnosis, I think it is abundantly clear that research and clinical practice is separated by a great wall for most patients.
The Working Group’s planning appears to be closed to the public, and we have no input onto the final questions. We wouldn’t even have this draft list if I had not managed to file a successful FOIA request. The anonymous Working Group will finalize the questions, and these will be posted publicly – although we have no timeline for that.
Non-Experts By Design
Supposedly, the Working Group is made up of ME/CFS experts. That’s the impression Dr. Maier gave at the May 2013 meeting, and by the P2P website. But the P2P Panel is a completely different story.
The P2P Panelists perform several functions: review the evidence report produced by the AHRQ review; attend a pre-Workshop webinar to discuss the evidence report and additional materials; attend the Workshop and ask questions of the presenters; prepare a draft panel report; and review and incorporate public comments to finalize the report.
Panelists can be nominated by members of the Working Group BUT there are significant restrictions on their expertise. Specifically, the panelists:
- May be knowledgeable about the general topic under consideration, but must not have published on or have a publicly-stated opinion on the topic.
- Must not have intellectual conflicts, such as participation in statements by professional societies or participation in advocacy groups on the topic.
- Must not hold financial or career (research) interests in the workshop topic.
Let’s be very clear about what this means. If someone has ever published on or made a public statement about the diagnosis and treatment of ME/CFS, he/she is disqualified. If someone has participated in statements from professional societies or participated in advocacy groups, he/she is disqualified. If someone has a financial or research interest in the diagnosis and treatment of ME/CFS, he/she is disqualified. Furthermore, there is no public comment period on the panel roster like there was for the IOM panel. In fact, it’s not even clear to me how far in advance we will know who has been appointed to the panel.
If the IOM process makes you mad, then this process should make you furious. There will be no ME/CFS experts on the panel that writes the Workshop report identifying methodological and scientific weakness in ME/CFS, suggesting research needs, and providing “an unbiased, evidence-based assessment of a complex public health issue.” The only involvement of experts will be through the Working Group and through the presentations made at the Workshop. I only see one upside to this arrangement: anyone who has been associated with the psychogenic model of ME/CFS will also be excluded.
This process may work very well for the “generally noncontroversial topics” that P2P is designed to address. For example, I can easily imagine the benefit of non-experts examining the state of research for a rare genetic disease. Only one other disease has been examined through P2P: polycystic ovary syndrome. The P2P workshop examined the current diagnostic criteria, causes and risk factors, and prevention and treatment strategies. There were only four panel members: an obstetrician-gynecologist, a cardiologist, the executive director of the American College of Nurse-Midwives, and the Executive Dean for Research at the Mayo Clinic. No patients or advocates spoke at this Workshop. It is not clear to me how well received the panel’s recommendations were in the PCOS patient community.
There are obvious problems with trying to apply this process in ME/CFS. First, there is no single body system to focus upon. While the PCOS Workshop could draw on endocrinologists, gynecologists and women’s health experts, what is the specialty pool for ME/CFS? Second, it is well known, and I believe generally accepted, that doctors and researchers without ME/CFS expertise will still have preconceptions about the disease. We need look no further than FDA for an example. It wasn’t until after the four-hour active listening session in April 2013 that FDA representatives, by their own admission, began to understand the seriousness of the disease, and this was a group of people who were familiar with ME/CFS to some extent. If the P2P panel is comprised of people with little ME/CFS knowledge and possibly negative preconceptions, and the Workshop does not include significant participation from ME/CFS patients and advocates, it seems unlikely that the best results will be achieved. Based on our decades of experience with misinformed scientists, clinicians, and policy makers, it is very hard to trust in such a process.
Bottom Line
Almost the entire process of this Workshop is being conducted behind closed doors. The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision. And the only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear.
So if you are worried about the lack of ME/CFS experts on the IOM panel, or if you think that the public will not have a sufficient opportunity to participate in the IOM process, pay attention! The NIH P2P process looks even worse. We cannot lose sight of the forest for the trees, and IOM is not the only moving piece on this chessboard.
What can we do? I believe that advocates must demand more information about the P2P Workshop, and must demand meaningful opportunities to participate. The planning and execution of the Workshop should be transparent if it is to have any legitimacy in the advocacy community. I urge you to participate in both the IOM and P2P processes at every opportunity – ask questions, provide input, and present a united front based on the truths we know about ME/CFS. We cannot wait until the end of the P2P process to make our voices heard, especially since this process will provide input into the IOM study.
Totalitarian.
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Thank you, Jennie, and to whoever is providing inside information. We need all the help we can get.
There’s a bright side to the panelist criteria: there will be no advocates for the psychological side, either. It strikes me that their goal was to keep the panel as neutral to study the existing evidence. I just don’t think excluding all the most knowledgeable people was the right way to go about it.
I agree that keeping out the people with overt psychogenic bias is a good thing. What I’m worried about is that they will not adequately screen the panel for less overt bias or misinformed opinions.
Thank you Jennie for this ‘unveiling’ of information to us.
Yes, this makes me mad! I can’t put it into words here how I feel. This is in my opinion, is a concerted, orchestrated effort by HHS to enable an outcome that they have desired and worked toward for the past 30 years. This workshop will serve as a direct data input for the IOM committee which will be forced to come up with the diagnostic criteria that HHS has desired, on a silver platter.
I am very interested to see what CAA’s and PANDORA’s reactions to this information will be. I can’t help but feel that HHS has been emboldened by the fact that they have gotten a nod to their actions contracting with the IOM and now they feel free to run with it and just blatantly destroy us.
Is there anything that HHS can do that will warrant them to stand up for us?
Hi Jennie,
I am saddened to see more obstacles this New Year for the ME/CFS community. It is true that when voices get louder, resistence grows. Yikes. Your last paragraph calls for action. Please let us know how, when and to whom we should direct it. Thank you so much for your vigilence.
Best.
another outrage. another insult. — rivka
@Robert Morley
I think it’s very clear to any person apprised of all the relevant facts and history here that HHS is not trying to be neutral, and certainly not trying to be accurate. The whole history of HHS over the past 30 years is entirely consistent with this being an attempt to warp the science of ME even more. Further, the secrecy of the whole process itself, and the details of the process such as the aims of the process and the actual panelists makes it obvious, they are trying to pull a fast one once again.
I really hope that the experts draft another letter to HHS demanding that this process be halted and also that 2 day CPET be adopted by the CDC CFS study. These facts all show a consistent pattern of continuing coordinated strategy to warp the science and definitions of ME.
They were trying to sneak this entire process by us and present us with a fait accompli. Thanks to Jennie for uncovering this scandal.
@Jennie, can you let us know how you think we should proceed in terms of finding out who the panelists are? Are you going to do a FOIA request on the subject? Obviously, it is crucial to know who these people are.
I’ve been told that the names of people on the Working Group will be released, but no one has committed to a timeline. The panel has not been selected, although the Working Group can suggest names, and it takes many months to do that selection. If the Working Group roster is not released soon, I’ll file a FOIA but that will take months to be released. I’m hoping my info is good and they will publish the list without that step.
Thank you for pointing out that the P2P webpage explicitly says that the P2P process is designed for topics that “are generally not controversial.” They realize that an evidence-based medicine approach will yield inaccurate results in the instance of a controversial illness such as ME, where the fake science has been stacked against us.
@Jennie Spotila DEFINITE ALARM-RINGING CONCERN as you stated with “less overt bias” and /or “misinformed opinions.” — This is MORE THAN possible; highly LIKELY and PREDICTABLE in the ‘MOVEMENT AGAINST pw ME/CFS’ and getting to the scientific biological answers–UNbelievable; yet, our MOST UNfortunate REALITY. Pls see info and link below as to VALID testament to those concerns.
Something I came across recently in viewing this link in the Huffington Post (11/20/2013) entitled The Most Prevalent and Devastating Disease Your Doctor Has Ever Heard Of (Jennifer Brea)–in the comments section–(in reloading to the next 10 comments)–posting by Justin Reilly on November 21, 2013. A breakdown on the credentials of the IoM panel re the GWI redefinition is given listing MANY ‘interesting’ points.
http://www.huffingtonpost.com/jennifer-brea/myalgic-encephalomyelitis_b_4303725.html
In this post, the point below was something I was previously UNaware of and really captured my attention–i.e. the chair of the IoM panel (GWI) — A DIRECTOR OF UNITED-HEALTH INSURANCE . . .
“1 (6% of committee), the chair of the panel, Dr. Shine, is both a Director of UnitedHealth Insurance (undisclosed in bio) and a past President of IoM.”
UMMMM—how BLATANTLY OUTRAGEOUS AND DEVIOUS is that!!!!!!! Talk about a PREDETERMINED OUTCOME to the DETRIMENT of the VETERANS. WHEN will ALL OF THIS be brought to JUSTICE ??
Next up for that INjustice — ME/CFS.
Head Bangers for sure with this NEW SECRET!! Thanks for your great detective work, Jennie, and keeping ‘on it’. AND the PLOT THICKENS . . .
I thoroughly disagree with the last paragraph of this blog article. I believe we must NOT PARTICIPATE in this. If we do, we are lending it credibility. What we need to do is FIGHT! These people are trying to KILL us! We should not help them make it appear that we are committing suicide!
These actions are thoroughly planned by HHS/CDC and NIH (and probably CAA and PANDORA). IF PATIENTS PROVIDE INPUT, IT WILL NOT CHANGE THE RESULT! All it will do is let HHS pretend that it is a legitimate process and that patients agree with it because they participate. Do not be misled.
Great work Jeniie. Many thanks. We need a sunshine lawyer desperately. Anyone know what groups do that?
The odd thing about the document Jennie links to is that it says that topics focused on by P2P should be in a scientific area that is “generally not controversial” and “have a primary or secondary disease prevention focus.”
There are controversies within the ME/CFS field so the first point is odd.
The second point is odd because we don’t know much about ME/CFS much less how to prevent it. And what “secondary diseases” are they trying to prevent? Depression, anxiety, OI, FM? Not clear.
@Patricia Carter The bottom line is exactly that–they ARE systematically working at KILLING us, as that will be the END result of ‘burying ME/CFS’–all their–i.e., HHS/CDC, NIH and ‘others’–PURPOSEFUL, PLOTTED AND PLANNED actions AGAINST us in their ‘MOVEMENT AGAINST PW ME/CFS evidence this DEATH—OUR DEATHS–and this is LITERALLY speaking–NOT figuratively!
Having to ‘live ??!!! our lives’ (a highly altered LIMITED definition of living life) in CONSTANT DEBLITATING ISOLATING DISEASE ALL THESE YEARS–with NO fix–is certainly NOT a choice of life for any of us. YET, as medical research is getting closer and closer to BIOMARKERS AND REPLICATIONS, the above government agencies et al—are CONTINUALLY PURPOSELY STRIVING to BURY us in ME/CFS by DISabling and putting a STOP to advancement of BIOLOGICAL SCIENTIFIC research.
This is CRAZZZZY and LUNACY and all soooo VERRRY VERRRRY WRONG–and–WE are NOT the CRIMINALLY crazy ones!!
NEWS FLASH to the ‘powers that be out there’—YOU CANNOT wave your magic CONSPIRACY WAND and make this HORRID disease disappear—as you continue in attempts to cover up this GLOBAL EPIDEMIC–THAT’S RIGHT–IT IS AN EPIDEMIC; JUST LOOK AT THE NUMBERS–your actions against us–in your ‘MOVEMENT AGAINST pw ME/CFS is a DIRECT reason why this EPIDEMIC disease continues to SPREAD GLOBALLY!!
How ABSOLUTELY STUPID AND NEGLIGENT YOU ARE . . . Please give YOUR collective heads a shake and lest you and/or your family and loved ones YOURSELVES get attacked by this disease think AGAIN about your FOOLISH NEGLIGENT ROLE in your OWN DEMISE–all in the context of POLITICS and your EGOS.
‘They’ will get CAUGHT up in this and HANG ‘themselves’ in this ATROCITY that THEY have created AGAINST us pw ME/CFS! ME/CFS has been a POLITICAL disease from the beginning–POLITICS has NO business in SCIENCE!! We are but ONE example of that.
BRAVO to the EXPERTS AND RESEARCHERS in ME/CFS continuing in their dedicated work on our behalves–they know the TRUTHS of this disease as BIOLOGICAL just as we pw ME/CFS do ourselves.
WE must think carefully and NOT allow ourselves to ‘fall into a/their trap’ and be ‘misled’–think carefully of ‘their’ strategies ‘against us’ and their INTENDED outcome ‘for us’. WE must WIN this WAR against us!!!!
Hi Jennie, forgive me if this is a dumb question– when you say the review will be conducted by OHSU, does that mean people in the working group will be from OHSU? I’m trying to understand to what extent will be OHSU’s involvement.
There are no dumb questions! The Working Group is not drawn from OHSU. As far as I can piece together, the Working Group should be ME/CFS experts, nominated by the federal people coordinating the P2P process. The P2P panel will be non-experts. The Oregon folks are responsible for the evidence review only, not the full process.
@Patricia Carter P.S.—As you say, Patricia, we must carefully consider our strategy in ‘when to engage’–therefore, giving credibility to the ADVERSARY–and when the BEST strategy is to DISENGAGE. THANK you for pointing this out.
While it is of course disturbing that this meeting is being held secretly and privately, is it any surprise?
Seriously, people can rant and rave all they like — which 2 years ago DID actually make us look like a bunch of “crazies”, thanks in large part to Patricia Carter and her friends at the me/cfs forums (remember XMRV and “AIDS in Africa”?) — but what people don’t seem to realize is that that highly paid lobbyists are the only ones with power in today’s government.
And seriously, when practically none of the drugs out there actually ‘cure’ any disease but rather just suppress symptoms for a few hours (and cause serious side effects), why is anyone looking to the government (i.e., the FDA) for answers? We need to find private investors willing to invest in private research to confirm what is already known about our complex illness and publish studies that proceed from there.
Jen, I have shared the following from this site and from Cort’s blog far and wide. I hope people will stand up and be counted. I would like to send my comment directly to the P2P. If you have a contact, can you please send it to me? I will encourage others to do the same. In healing and hope, Celeste
More of the same? Jen explains the lack of transparency, which has us all wondering WHY? This seems status-quo when it comes to healthcare and our government. Years ago, while a member of ASHET (American Society of Healthcare Education and Training), the same thing occurred. Just after DRGs (developed to help classify medical diagnosis and tests for Medicare billing ) were instituted, a government panel discussed the role of HMOs and insurance capitation which eventually led to the conundrum of the healthcare delivery model that we have today. Not ONE doctor, nurse or other HCP was invited to this panel, it included reps from insurance carriers, politicians, et al, that had no interest in patient outcome. We all know what happened from there. How can we ever get it right without experts sitting on panels that make these decisions? Thirty years later and here we are, different day, but more of the same.
This is status quo. It is my understanding that the IOM in not legally bound to disclose what you are saying “is secret”. This is the process. Am I against the IOM taking over this contract? YES. However, in my opinion, this event was in part initiated by a split in advocates running around advocating for a name change from CFS to ME in the hopes that a more important name would make CFS a more important illness. It is my opinion, that if we want to advocate, we need to do so with caution and with political and professional advice. The IOM took over GWI for various reasons. I doubt the IOM will get a hold of Autism or MS. The reason GWI and CFS were targets for takeover must be looked at and acknowledged.
I think it’s important to distinguish between the IOM process and this NIH process. They are different, but overlapping. The requirements for confidentiality and disclosure are different between the two.
My brain is really foggy and I have read this article a couple of times and cant understand what is going on. What I think is going on is the NIH is holding a secret meeting but what are they trying to do. What is the meeting about?
Thanks
readyforlife
readyforanewbrain
I know this article is really dense. NIH is planning a workshop on the diagnosis and treatment of ME/CFS, including the impact of definitions on research. The planning meeting yesterday and today is closed to the public, including who was invited to attend.
I’m trying to make sense of this also. I’ve been trying to work it out since yesterday. I had no idea this was going to be happening, and found it a bit hard to switch gears from the IOM study. Please let me know if I have things wrong Jennie.
So…. The NIH Working Group (roster unclear but possibly some experts) meets yesterday and today (behind closed doors) to clarify what questions the Workshop will address. This same group will then recommend what research is to be given to the P2P panel (non experts,) who will try to answer the questions based on the evidence/research provided them.
IF this is correct then it would seem critical to me that the P2P panel be
a-unbiased
b-in possession of pertinent research
(neither of which advocates have control over)
Thanks Jennie for being on top of this. I look forward to upcoming posts and finding meaningful opportunities to participate. Transparency is incredibly important.
Almost, Darlene. Here’s the step by step:
1. The Working Group (roster unknown) is meeting behind closed doors to clarify the study questions.
2. Those questions will be used by the Evidence Practice Center to conduct research and write a report summarizing what the research says about those questions.
3. The Working Group plans the P2P meeting.
4. The research report goes to the P2P panel (non-experts).
5. Experts present at the P2P meeting.
6. The P2P panel (non-experts) takes the report and what they hear at the meeting, and they issue a summary report that will probably include recommendations about where the science should go from here.
I know. Clear as mud.
@Jennie Spotila
Thanks Jennie, that was very helpful. I look forward to your next post!
Jenny: Thanks so much for your tenacious reporting. It’s truly invaluable.
Kathy: I agree with you about the critical need for private investment vs. waiting around for government funding (which would probably be small, if at all). Theoretically, who would lead that charge? The CAA? (Ha!), advocates? (not in a position). Perhaps Jen Brea’s film can be a tool for soliciting private funding….
Julia: I wholeheartedly agree with you that an organized, cohesive and well-advised advocacy arm is the most effective. (Once again, I offer Stand Up! for HIV/AIDS). But, how to achieve that and what if other advocates don’t agree?
@Julia Hugo Rachel
I disagree. IMO, the thrust behind a name change isn’t so much because “ME” sounds better it’s because “CFS” isn’t defining a discrete condition, it’s only characteristic is “fatigue”. As should be crystal clear this is a problem because research into “fatigue” concludes that the solution is CBT, GET and anti-depressants. No tinfoil hat is needed to see that there is pressure to reduce healthcare costs so for “CFS” the above solutions are “codified”. Autism is completely a different ball of wax as the focus is on children so it is more politically difficult to cut funding to that population. However, it will be interesting to see what happens as these kids reach adulthood and are unable to care for themselves.
The only hope for advocating with “caution” is if Jen Brea’s and other efforts to convince the public that this population isn’t just “tired”. If public opinion can’t be turned and there is no outside pressure then the Feds can do whatever they want with impunity. One way or another these committees (the Feds) have to feel the heat.
@floydguy, I agree.
@Jennie Spotila, thanks for the short summary of the steps, very helpful!
@Kathy, I agree that more private funding (from foundations and fundraising) is crucial. But, it is also crucial that we keep turning up the heat on HHS, to at least stop the harm they are doing, and hopefully a much greater amount of bona fide research.
Thank you Jennie for all you do!!! This should just blow my mind but for some reason it doesn’t. Our government is on a power trip and should remember WE THE PEOPLE are the ones who vote and pay taxes and should have a say. I’m not sure why we have CFSAC meetings when the NIH just does what ever they want.
@Jennie Spotila
Thank you Jennie for the legwork on this, and I hope you’ll keep us informed! Thanks to Lori for passing on this information …
In all the various public postings one thing is very VERRRY CLEAR–WE are sooooo many terrilby sick people with ME/CFS and we all WANT so very much to get back to health and get our lives back–to actually ‘LIVE’ our lives; we DESPERATELY need the SCIENTIFIC BIOMEDICAL research and answers to help US and to STOP others from getting this HORRID ‘invisible’ biological disease.
Thank you so much for checking in, Dr. Lapp, and letting us know that you and other dedicated experts are out there!!! THANK YOU ALL!!!
I don’t understand why they keep selecting unsuitable venues. IOM traditionally works on treatment reviews and questions of policy, and they use methodology which was designed for treatment reviews. While its suitability is questioned even for treatment reviews, there should be no question that it is unsuited to questions of definition.
And here the Workshop is also using something expressly stated to be unsuitable for what they are doing.
What is going on? Does this open an avenue of official objection?
I am investigating several avenues of official objection. I’ll provide more info as soon as I can.
It is time Jennie to file a lawsuit in your jurisdiction against HHS and NIH similar to the Federal filed by Jeannette Burmeister if you have received no response or the response was not adequate!
It is quite apparent over these months that HHS and the NIH will not listen to patient advocates or researchers unless forced by an outside intermediary that will enforce both Federal Law, Statute and our U.S. Constitutional rights which we have as citizens. Jeannet provided a great template to use.
When are you going to file?
We need your help in filing a lawsuit. The more we file, the more pressue will be imposed on HHS and NIH. After reading the latest from Anthony Hardie on the Gulf War Veterans, the executive branch will only respond if an outside agency forces them to disclose information that is within the right of every taxpaying citizen to obtain.
http://www.91outcomes.com/2014/01/anthony-hardie-what-va-leadership-needs.html
1) The January 2012 version of the Gulf War Illness Research Strategic Plan, developed by a consensus of three advisory bodies including the NRAC, RAC, and Gulf War Steering Committee — and a couple dozen scientists from inside and outside the VA. To date, VA has done little of what’s in the plan, and rewrote and distorted the portion on how a new GWI case definition should be developed to meet their own plans to give it to a psych- and stress-focused IOM panel on “Chronic Multisymptom Illness” (CMI) that seeks to lump all multisymtom illness issues from all eras into one big pot. Imagine the potential of success in finding treatments then…. Next to zero. SEE: http://www1.va.gov/RAC-GWVI/VA_draft_strategic_plan.pdf
2) Written testimony submitted by 14 Gulf War veteran leaders. To date, there has been no response and no action. SEE: http://www.scribd.com/doc/115956730/Testimony-DAMA-Lost-Records-FINAL
3) My most recent Congressional testimony from March 2013, with a long list of recommendations that included and built on the recommendations in #14, none yet heeded by VA. To date, there has been no response and no action. SEE: http://veterans.house.gov/witness-testimony/mr-anthony-hardie-0
4) The June 10, 2013 letter from all the Gulf War veterans on the RAC to VA Secretary Shinseki, with a lot of history and recommendations, which built on #2 and #3 above. That letter didn’t even merit the courtesy of a VA response, let alone any action on the substantive issues raised in that letter. SEE: http://www.scribd.com/doc/150958485/RAC-Gulf-War-Veterans-Urgent-Letter-to-Sec-Shinseki-06-10-2013
5) The August 26, 2013 letter from Paul Sullivan and a dozen other Gulf War veteran leaders, many active in this Facebook group, to Dr. Robert Jesse, who was active and vocal in this week’s RAC meeting. To date, there has been no response and no action. SEE: http://www.scribd.com/doc/197084024/Sullivan-Jesse-Gulf-War-08-26-2013-2
My administration is committed to creating an unprecedented level of openness in government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.
— President Barack Obama
The ME/CFS patient community is getting swamped with being reactive to a bunch of stuff but we need to be proactive as well. Jennie, do you think it would be a good idea to advocate for the CFSAC to recommend that ME/CFS be taken out of the ORWH and put back into the NIAID?
A lot of people reject that option because they are unhappy with what Tony Fauci has done with ME/CFS already. To me, the issue is resources. If we move back into an Institute, will we get better financial support from NIH? I honestly don’t know the answer to that question. The issue really seems to be the grant review panels, rather than the paylines. Multiple researchers have complained about their grants getting trashed by reviewers. I’ve filed FOIAs to get the rosters for the CFS Special Emphasis Panel, and was denied. I appealed and am awaiting the outcome of that appeal. The problems are much bigger than just the grant review or which Institute/Division houses the program, though.
Historically there has been great reason to distrust the government employees who have been involved with CFS/ME but I’m tempted to try to be encouraged or optimistic about this. It’s possible that very fresh eyes can take all the info the founding ‘mothers and fathers’ put years into and percolate out some new ideas. I don’t think it will be detrimental to the cause. I know why we all have reason to distrust, but the advances made in the last 5 years are really deep and vast compared to previous work. Much of this advance has been made possible by improvements in technology and much because the founding researchers have laid an impressive foundation to build on. I also can understand not having people with research or intellectual rights involved. I’d just suggest for folks not to get too discouraged and lets hope we’re still moving forward. Lets try a bit of optimism. This effort will not derail the advances that are coming – I feel sure.
Response to K. Brown
Hmmmm . . . and YET knowing the advances you’ve spoken of above, the ME/CFS EXPERTS and RESEARCHERS are calling for adoption of the CCC and ABANDONING the IoM contract–“Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.” — Quoted directly from the EXPERTS’ and RESEARCHERS’ letter sent to Sebelius September 23 AND October 25, 2013.
@K. Brown
I’m glad you’re optimistic but I’m not and I say this as someone who has tried to work with the government on ME/CFS issues. The problem with the P2P program is that the panel members involved are REQUIRED (this is not a choice, it is written into the program) to :
a. “not have published on or have a publicly-stated opinion on the topic” – does that mean
people who have published research or clinical papers on ME/CFS are excluded? That
wipes out most ME/CFS researchers and clinicians
b. “not have intellectual conflicts, such as participation in statements by professional
societies or participation in advocacy groups on the topic” — so no one on the IACFS/ME
Primer or in any science (not just patient) advocacy group having to do with ME/CFS
c. “not hold financial or career (research) interests in the workshop topic.” — so no
purely clinical doctors or other staff either? Clinical docs who don’t do research do see
ME/CFS patients and are paid (“financial interest”) for it.
Who is left then? We need to clarify what those requirements mean. Taking everyone out with ANY opinion or career interests in ME/CFS means a possibly super-biased (ironically) panel is left. As Jennie writes, this may be less of an issue say with diabetes, high blood pressure, or other common illnesses but not ME/CFS.
And don’t forget these panel members with NO interests are suppose to write their document in THREE DAYS after a 2 days workshop.
[Details: http://prevention.nih.gov/p2p/default.aspx%5D
ANd sorry, while I appreciate all efforts made by ME/CFS researchers and read the research papers regularly, there is not enough blockbuster research to turn the ship around as quickly as you or I would like it. Unless you can cite something specific other than the antiviral and rituximab research, which I think is great but doesn’t seem to have caught the attention of the government.
This is a case of preparing for the worst first and then hoping for the best a far second option.
@Jennie Spotila
Thank you, Jennie!
Great reporting, as always, Jennie. However, I wonder if you could address what the practical, tangible consequences of the Workshop will be. Why does it matter in the end? My brain is in total post-holiday crash mode so do pardon me if this question has been answered already. Certainly it is deeply disturbing that ORWH appears committed to a policy of shutting out patients and ME/CFS professionals (and it should be an overriding goal on our part to change this at NIH/HHS — which can only happen with posts like this). But what will the Workshop be doing besides coming up with a committee report that nobody will read besides us (unlike the IOM report, which will be read by a lot of journalists and clinicians because it’s from the IOM)? It’s not like there is a vast ME/CFS research program (if only!) that might be changed for the worse or a load of research money we might lose (though I can see where there could potentially be a lot of research money gained by new research funding guidelines). I’m not sure I understand how potentially dire this development is beyond reinforcing the already explicit disdain in which ORWH holds the ME/CFS community. Then again, my apathy may well reflect just how sick I am at the moment. 😉
I will say that this latest development keeps making me replay (in my head, too sick to youtube) Susan Maier’s comments during that infamous 10-minutes at the May 2013 CFSAC meeting. It was just so bizarre given the context. I haven’t been able to decide whether I should feel badly that she’s been mistreated by members of our community or if I should be appalled at how badly she’s treating us by whining about how much work this whole ME/CFS thing was turning out for her (not that it’s much work for us patients, of course) and implying how ungrateful we were in insisting on having a say about what she did with our disease. Her actions since then have me leaning pretty heavily toward the latter.
As always, you’re a great asset to our community, Jennie. Thanks.
THIS is the most important question! Why does it matter?
The panel (remember, totally non-expert) will write a report after the workshop. They have a day or so to do it, and they work in executive session (meaning only they are in the room). That report is then posted for 15 days of public comment.
So what will be in the report? Take a look at the report for PCOS: http://prevention.nih.gov/workshops/2012/pcos/docs/FinalReport.pdf
The recommendations (pages 6-8) included:
Do any of us want a panel of ME/CFS novices – who were selected completely out of the public eye with no opportunity for us to comment – to issue recommendations on diagnostic criteria, biomarkers, research and treatment? Isn’t this why almost the entire advocacy community has been so opposed to the IOM process? IOM has tried to mitigate the situation by appointing a panel that is half ME/CFS experts, but this panel will have NONE.
It scares me.
ROGER that, Jenny–S C A R Y !!! NO ME/CFS EXPERTS here on P2P . . . Things are getting ‘smellier’ . . .
YET, interestingly, NIH has ordered this as so–that the totally NOVICE panel of P2P write a report and then that P2P feeds into the IoM contract, if I’ve got that understanding right.
Soooo—simple math as we know it is NOT adding up here–and hasn’t been adding up and making sense at ALL ALONG THE WAY!!!! The sense I am talking about, of course, refers to THE TRUTH and advancing the biological scientific research for ME/CFS.
Contrarily, it DOES make sense from the point of view of HHS and HIH, et al–because they are taking the steps they deem necessary to BURY us. We’ve said this all before; and ‘they’ keep producing more evidence all along the way. Surprise–surprise !!!!
Let’s question this further DEBACLE with P2P NOVICE panelists. Is this set in motion to gain ‘their balance,’ and, therefore, further sabotage, as there are ‘some’ experts on the IoM committee with the majority of NON-experts—gotta even that out a bit for ‘themselves.’
THE MAIN and CRUCIAL point in all of this is that — The the ME/CFS EXPERTS have called for adoption of the CCC and ABANDONING the IoM contract–”Worse, this effort (the IoM contract–which has branched off to include the P2P NOVICE panel report) threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.” — Quoted directly from the EXPERTS’ and RESEARCHERS’ letter sent to Sebelius September 23 AND October 25, 2013–(my bracketed phrase).
Soooo–NO–the IoM contract having ‘some’ ME/CFS experts is NOT good enough — it is merely an attempt to ‘placate’ the ME/CFS population.
Being told that the IoM c’tee HAS to be set up this way because these are ‘the RULES’–i.e., a combo of experts and non-experts–is absolutely RIDICULOUS — and further shows that the IoM ought to have NO involvement with redefining ME/CFS.
THAT is why the ME/CFS experts have called for adoption of the CCC and NO IoM contract; the IoM is completely UNequipped to do a proper job–that is to say for the ME/CFS population and the experts and researchers–BUT it is MORE than obvious that a COMPLETELY INACCURATE AND SKEWED outcome result of the redefinition of ME/CFS is what the government has planned!!!!!!!
P.S. ALSO to mention — the ‘literary review’ aspect–which basically are the parameters around the IoM contract using OUTDATED MISinformation leading to INACCURRATE and MISleading conclusions!!!!!!! AND ‘they’ know that—AND so DO WE!!!!!!!
@Jenny #46:
But will anybody be listening to this panel? Are the recommendations binding? Will they be published? If so, will it be a high-impact journal? I can certainly see how it might be used within the NIH to shape policy. My worries would be how it might affect research priorities and the funding associated with them, as well as, say, Medicare/Medicaid coverage of treatment. According to the P2P webpage with regard to how this report will be used:
Each P2P workshop results in a technical brief and panel report on the workshop topic. Every panel report reflects an independent panel’s assessment of the medical knowledge available at the time the statement is written; as such, it provides a “snapshot in time” of the state of knowledge on the workshop topic. It is not a policy statement of the NIH or the federal government.
My reading from this is that this P2P report is an internal NIH paper and that the recommendations are “non-binding,” if you will. There is very little ME/CFS research to cut at this point. While I don’t know about Medicare, Medicaid already will not cover treatment for ME/CFS. I don’t know how this P2P workshop report could make our situation worse, but I certainly can see how it can potentially keep things from getting better. And, of course, there is always the possibility that it will actually make things better.
I’m looking forward to reading what more you find out. While the conspiracy-theorists may yet be right that the IOM report, CDC multicenter study, and this P2P report are all an orchestrated plan to keep us “mentally ill”, I’m more inclined to agree with Cort that HHS is genuinely trying to finally do something about ME/CFS. Unfortunately, they don’t seem to have a clue about how to deal with ME/CFS patients — or any patient group, for that matter. Few patient groups have had to be as vigilant as we have in paying attention to what our government is doing with regard to our disease and NIH/ORWH bureaucrats appear completely bewildered (and defensive as hell!) with our “interest” (or even why we are so damn “interested” to begin with). They also don’t appear to be especially quick on the uptake (to say the least!) with regard to dealing with us either.
The report will be public, although I don’t know if it will be published in a peer reviewed journal. It’s hard to know because the only other such report (on polycystic ovary syndrome) was published just a year ago. I haven’t been able to determine exactly what the impact has been, beyond the press coverage.
BUT we do have reason to be concerned. From what I’ve heard, the evidence review is likely to “confirm” that CBT and GET are effective treatments. That evidence review will certainly be published in a journal (the last one was in 2001). So if the P2P panel of non-experts see that in the evidence review, even though the workshop presentations will likely contradict it, what recommendations is the panel going to make on treatment? And if a panel of respected scientists (with no ME/CFS experience) endorses CBT and GET as effective treatments, will it really matter if it is not stamped “official NIH policy”?